It is a pleasure to be with you for this year’s GRx+Biosim meeting and to join with my colleagues in sharing some of the important work being done at FDA to help make essential medical products available for more patients. I want to thank AAM for all your important work in support of greater accessibility of essential prescription medications.
Ensuring that patients who need safe and effective medicines have greater access to them is a public health priority and essential for reducing health disparities and advancing health equity. It is central to the work of the FDA, and it also has been a key element of my work throughout my career.
One of the most important means for achieving this goal – and an FDA priority – is supporting innovation to help increase the availability of generic and biosimilar medicines which can make a critical difference in the lives of American patients and consumers.
As you understand, the concept of accessibility – ensuring that more patients get the medicines they need to treat their conditions in a timely and affordable manner – is inevitably and inextricably tied to the principles of affordability and equity.
It’s not enough just to have medical science breakthroughs if that science doesn’t get translated into products that people can use. That’s part of what the FDA is all about – helping facilitate and support innovation and move it into the hands of patients and consumers to help make their health and lives better.
While our agency does not play a direct role in drug pricing, we can -- by encouraging development of lower-cost generic and biosimilar products –support competition in the health care market.
And we know just how much of an impact the expanded availability of generic and biosimilar drugs -- whose prices can be a fraction of the brand-name product of the same medication -- has made.
As they say, the numbers don’t lie.
As made clear in the AAM’s 2021 report, the savings impact to Americans as a result of the lower costs of those generic and biosimilar products is enormous.
Last year, Americans saved $338 billion by using generics and biosimilars. That’s an increase of $18 billion from 2019.
Even in the face of a number of challenges in the biosimilar space, new launches and improved utilization led biosimilar savings last year to grow by more than three times the $2.5 billion saved in 2019, with an especially high impact in oncology.
Generics today continue to account for 90 percent – 9 out of 10 -- of all prescription drugs dispensed in the U.S. I think it’s important to point out that the savings achieved through the use of generic drugs, which is based on that 90 percent figure of all prescription drugs sold, actually involves only 18 percent of all prescription drug spending.
To some, that may seem a bit counterintuitive. But it underscores a key fact -- that a relatively small number of brand-name products accounts for the vast majority of spending on prescription drugs. This is especially true for biologics.
There are two important conclusions we should gather from this.
First, some very important and necessary drugs are extraordinarily expensive. (No surprise there.)
And second, there continues to be enormous opportunities for growth in the generic and biosimilar space.
During this conference, you’ll hear from several FDA leaders about some of the ways we’re working to support this development. Our goal is to apply cutting edge science and maximize scientific and regulatory clarity to support industry in the development of alternative approaches for demonstrating bioequivalence.
This is particularly important, for instance, in the work being done around complex generic drugs. As you know, these drugs are critical to the treatment of multiple medical conditions, and, because they can be more scientifically challenging, time consuming, and expensive to develop, often lack adequate generic competition.
This approach has also been a key focus of our Drug Competition Action Plan (DCAP). We want to bring greater efficiency and transparency to the generic drug review process and remove barriers to generic drug development and market entry, especially for complex generics.
It’s hard to overstate the importance of the user fees that we receive through the GDUFA and BsUFA programs to this work.
I’m pleased that, working with our stakeholders, we made progress this year on GDUFA’s reauthorization, and that our successful negotiations with industry will enable the proposed agreement to go to Congress for enactment in 2022.
Similarly, for the reauthorization of BsUFA, we worked with industry on a number of proposals, including some that maximize scientific and regulatory clarity, and ways to enhance efficiency in the review process. We’re nearing the completion of that process as well.
User fees don’t just support our work; they help provide the stability that allows these programs to succeed and flourish, which in turn helps ensure Americans continue to have access to safe, effective and more affordable medicines.
This has been especially important over the past 19 months, as we have taken on enormous additional responsibilities responding to the COVID-19 public health emergency.
Our work to expand competition and increase the availability of generics and biosimilars has even more importance today as part of the effort to find treatments and cures in response to the COVID-19 pandemic.
These efforts also support another important goal and benefit of generics, to help respond to and prevent shortages of individual drugs.
Last year, for example, hospitals experienced an extraordinary demand for dexamethasone, a commonly used and inexpensive corticosteroid, after researchers released data suggesting the therapy could possibly improve the odds of survival in the sickest COVID patients.
During a three-day period in June 2020, use of the drug spiked more than 600 percent, leading to a shortage of several injectable versions, impacting non-COVID patients who used the treatment. The FDA’s prioritized review of a generic dexamethasone was intended to help alleviate some of this shortage.
This is just one example of dozens of generic drug approvals – such as anti-infectives, paralytics, supportive fluids, and other products used in patients with COVID-19 – that have been prioritized over the course of the pandemic to help address the increased demand for certain product.
I’m pleased to say that even as we have answered the nation’s call during this public health emergency, we’ve continued to meet our regular public health priorities, thanks in large part to the diligence and commitment of the FDA staff.
I also want to emphasize that as we’ve taken on these additional responsibilities, we’ve maintained FDA’s gold standard of evaluating products based on quality data and sound science, and largely continued to meet our GDUFA and BsUFA commitments for reviewing applications in a timely manner.
We’ve also achieved some important advances in non-COVID generics and biosimilars during this period.
In FY 2021, for instance, we approved or tentatively approved 836 abbreviated new drug applications, including 679 final approvals and more than 90 first generics.
ANDAs for first generics are especially important because they are the first approval by FDA that permits an application holder to market a generic drug product in the United States. FDA considers first generics important to public health and prioritizes their review.
The noteworthy first generics approved this year involved treatments for a range of diseases, including diabetes, arthritis, ulcerative colitis, anemia, and a number of different cancers.
We’ve also had a very positive and productive year in the FDA’s biosimilars program.
We approved the first interchangeable monoclonal antibody product and the first interchangeable insulin product, both great examples of the collaboration and cooperation across the agency that goes into these reviews.
We have now approved 31 biosimilars for 11 different reference products. And the future looks even brighter, with interest continuing to grow.
As of October 1, 94 programs were enrolled in the Biosimilar Product Development (BPD) Program. And CDER has received meeting requests to discuss the development of biosimilars for 46 different reference products.
This isn’t to say that the pandemic hasn’t taken a toll on some aspects of the FDA’s work.
Some of the most important tools in our arsenal for ensuring the safety, effectiveness, and quality of the products we regulate are our review, surveillance, and compliance efforts, including the inspections we conduct of manufacturers.
During the pandemic, we have been forced to adjust some of our processes and guidances to maintain the appropriate level of review to fulfill our mission to protect public health. Thus, we acted to ensure the safety of FDA regulated products, as well as protect the safety of our inspectors and the staff of firms subject to FDA inspection.
We employed a number of tools in support of our risk-based approach to evaluate facilities, as appropriate, including remote assessments, remote interactive evaluations, and import alerts.
We used our authority under section 704(a)(4) of the Food, Drug, and Cosmetic Act to request records in advance or in lieu of an inspection for drug and biological products and reviewed trusted foreign regulator inspection records under existing Mutual Recognition Agreements (MRA).
As a result, the FDA has been able to act on applications in a timely manner over 90 percent of the time across our User Fee programs.
At the same time, there has been residual impact in some areas, including the biosimilar industry. Because the BsUFA program is small relative to PDUFA and GDUFA, a missed goal can have an outsized impact on on-time action performance goals.
I’m pleased to say that as of July, we began resuming normal operations for domestic inspections, what we call the “base case” scenario of our Resiliency Roadmap for FDA Inspectional Oversight.
Moving forward, we will continue to build on the approaches we’ve taken and the tools we’ve used in adapting and prioritizing risk-based deployment of our inspection resources, while working to resume regular operations.
The FDA’s support of generics and biosimilars shares the goal that is at the core of much of the agency’s work – to protect and promote public health by helping to ensure that Americans can get safe and effective medications when they need them. By encouraging greater competition and accessibility we can help achieve this.
I’m very pleased that this goal is a focus of President Biden’s as well. In an Executive Order on Promoting Competition in the American Economy he identified the lack of competition as a key driver for problems across various economic sectors.
Recently, the Assistant Secretary for Planning and Evaluation of HHS prepared a report for the White House Competitiveness Council, which advances a number of principles for equitable drug pricing reform.
As the report notes, Americans spend more than $1,500 per person on prescription drugs and pay prices that are far higher than any comparable nation. Prices for brand name drugs are rising faster than inflation. The result, as the report documents, is that many Americans have failed to take prescribed medications because of their cost, resulting in harm to their health care and health.
As I said at the outset of my remarks, the FDA does not have responsibility for pricing of medical products. But we can play a role in improving and promoting competition throughout the prescription drug industry, and, as the HHS report suggests, support advances that strengthen supply chains, promote biosimilars and generics, and increase transparency.
Promoting competition can help lower the prices of prescription drugs, thereby making them more accessible to people who need them, improving health care, and furthering progress toward health equity.
We look forward to continuing to work with you to develop ways to apply the best science in support of innovation and the advancement of our shared goals.
By increasing competition and expanding access to quality generic drugs and biosimilars, we can continue to make a difference in the health of so many.